The Australian TGA and European Commission have announced changes in the EU / Australia MRA taking effect January 1, 2013. The changes will reduce the scope of the program for new certificates issued, excluding AIMD and class III MDD until a new confidence building starts. It is expected that a meeting will be held in March in Nice, France to discuss how to start building confidence again on the new program.
The following preliminary transition arrangements have been agreed:
- Conformity assessment certificates issued under the current MRA for medical devices will become excluded from the scope of the MRA by the Amending Agreement, and will continue to be valid after the Amending Agreement comes into force until the certificate expiry date or five years from the date that the Amending Agreement comes into effect, whichever is earlier.
- Conformity Assessment Bodies that are designated under the current MRA to issue certificates for medical devices will become excluded from the scope of the MRA by the Amending Agreement, and will be considered to be designated under the Amending Agreement for the purpose of maintaining such certificates until the certificate expiry date or five years from the date that the Amending Agreement comes into effect, whichever is earlier.
- Any new conformity assessment certificates issued under the MRA once the Amending Agreement comes into effect must be issued according to the provisions of the new Amended Agreement.
TGA encourages sponsors to contact their manufacturers to confirm that they will continue to hold appropriate certification for devices entered on the Australian Register of Therapeutic Goods (ARTG) once the Amended MRA comes into force. The amending agreement can be found here.Some of the changes include:
- A rule of origin clause: Manufacture in Europe cannot be granted for refurbishing etc, nor for labeling, final packaging, sterilization etc. Production should truly be done in Europe. This previously was in the MRA itself, and is now in more detail in the sectoral annex.
- An extension of scope: Radioactive medical devices of lower risk classes will be included in the MRA.
- A new 2-year long confidence-building process for the purpose of strengthening confidence in the designating systems of each of the Parties will apply for the following medical devices:
- active implantable devices as defined in the legislation referred to in Section I; in Section I reference is made to MDD, AIMD and TGA/TGR;
- devices that are classified as class III devices under the legislation referred to in Section I;
- medical devices that are implantable intra-ocular lenses;
- medical devices that are intra-ocular visco-elastic fluids; and
- medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease.
Some changes to the precise exclusions, reducing the scope in some detail for combination products with medicines or biologicals:
- medical devices that contain or are manufactured using cells, tissues or tissue derivatives of animal origin that have been rendered non-viable, where the safety with regard to viruses or other transferable agents requires validated methods for elimination or viral inactivation in the course of the manufacturing process;
- medical devices that contain tissues, cells or substances of microbial, bacterial or recombinant origin and are intended for use in or on the human body;
- medical devices incorporating tissues or tissue derivatives of human origin;
- medical devices incorporating stable derivatives of human blood or human plasma that are liable to act on the human body in a way that is ancillary to the device;
- medical devices that incorporate, or intend to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device; and
- medical devices that are intended by the manufacturer specifically to be used for chemical disinfection of other medical devices, except for sterilizers using dry heat, moist heat or ethylene oxide.
IVD remains excluded for now, but will be added once the Australian legislation for IVD is in place. BSI will monitor all developments and issue further information as it becomes available. Please contact your Scheme Manager for further information regarding conformity assessment certification under the EU / Australia MRA. If you have any additional questions, please email us at eu.medicaldevices@bsigroup.com.
